“Our quality management systems and supporting services are delivered through the infrastructure we’ve created with Medrio and JReview.”
SAN FRANCISCO (PRWEB) July 17, 2018
MANA RBM, a Colorado-based contract research organization (CRO) specializing in risk-based monitoring (RBM) services, has joined the Partner Program at Medrio, a leading software as a service company providing cutting-edge eClinical tools for clinical trials. The new partnership comes on the heels of MANA RBM integrating Medrio EDC with JReview®, a clinical review and analysis tool provided by Integrated Clinical Systems, Inc. to create, in combination with MANA RBM’s proprietary methodology, a complete RBM solution for clinical trials. The complete solution is ready to implement for organizations seeking a robust and effective approach to RBM.
“Our new solution delivers comprehensive quality management methods and systems to successfully implement RBM,” said Penny Manasco, M.D., founder and CEO of MANA RBM. “Our quality management systems and supporting services are delivered through the infrastructure we’ve created with Medrio and JReview.”
As a Medrio Partner, MANA RBM will receive access to specialized training sessions customized to its needs, tailored customer service, and numerous other benefits that will further empower them to provide fast and top-quality data management services to their clients. MANA RBM cites the value of Medrio as a component of its RBM solution as a primary factor in its decision to join the Partner Program. Dr. Manasco also cited the quality of customer support provided by both companies involved in the integration: “The excellent support Medrio and Integrated Clinical Systems constantly provide show that both companies listen well to determine your needs and solve your problems. They care a lot about making their customers successful. That was a major motivating factor for us choosing their platforms to build out this RBM solution.”
The solution allows organizations implementing RBM and the new ICHE6(R2) Good Clinical Practice Guidance to work off a consistent yet customizable infrastructure, thereby reducing the expensive consulting process that often goes into tailoring an RBM infrastructure to an organization’s particular needs. “This is a much more consistent approach,” commented Eric Herbel, President of Integrated Clinical Systems, Inc. “It can of course be tailored to each user, but basically, it’s ready to go and completed.”
“We customize everything specific to the protocol, but the study management and other elements of the basic infrastructure are already there,” added Dr. Manasco. “People can start right away, and they can do it within their study budgets.”
The RBM solution is a recent example of the utility of software integration in clinical research today. By providing application programming interfaces (APIs) for integrating eClinical systems, Medrio facilitates access to a wide array of clinical trial processes, like RBM, while keeping its internal resources dedicated to providing top-tier EDC, eSource, and ePRO. “We’ve seen a lot of our users successfully utilize our APIs to expand their use of Medrio beyond our native products, and MANA RBM is just the latest example,” commented Mike Novotny, founder and CEO of Medrio. “We’re honored they’ve elected to join the Partner Program, and are excited to keep working with them in the future.”
JReview® is a registered trademark of Integrated Clinical Systems, Inc.
About MANA RBM
MANA RBM designed new, patent-pending methodology to specifically meet Regulatory Guidance for Risk Based Monitoring (RBM), eSource, and ICHE6(R2) Good Clinical Practice; not retrofitted practices from older, trial oversight approaches. Our complete RBM technology solution incorporates Medrio and JReview, which can be deployed for trials the Sponsor decides to run alone or in conjunction with MANA RBM's RBM monitoring services (e.g., subject monitoring, central trend analysis, data management). MANA RBM's technology tool suite includes a comprehensive quality management system used to manage clinical trial quality. We also offer a proprietary Site Tracker Analyzing Risk (STAR) for managing site risks. We use direct data entry or eSource to allow immediate, remote oversight of subjects and rapid correction of errors. MANA RBM focuses on high risk data and processes (not just analysis data) identified through our proprietary Risk Assessment service with full traceability to our oversight tools. Our proprietary RBM reports, hosted in JReview, facilitate comprehensive oversight, better quality, and cost savings. MANA RBM developed its remote trial management approach to ensure all data and documents were available remotely for immediate review. These proven processes, including SOPs, Work Instructions, and Training are provided to Sponsors that want to run trials internally. Instead of months of discussion and continuing costs, Sponsors launch Risk Based Monitoring and comply with ICHE6(R2) within weeks.
Medrio is a leading healthcare technology company providing eClinical solutions including EDC, eSource, and ePRO for clinical research. Founded in 2005, the company's cloud-based software platform and mobile suite of products deliver fast, flexible, and easy-to-use tools for the collection and management of clinical data and patient reported outcome responses. Study sponsors and contract research organizations have used Medrio extensively across drug, device, diagnostic, and animal health trials. Medrio has extensive experience in all study phases and leads the market in early-phase trials. The company serves over 500 customers globally, with headquarters in San Francisco and offices in numerous domestic and international locations. For more information, please visit http://www.medrio.com.